Please review this safety information.

Below you can learn about the risks and side effects of ADVAIR. This, however, is not all of the safety information, and it does not replace talking to your healthcare professional about your medical condition or treatment. Please see the complete Prescribing Information, including Patient Information, for ADVAIR DISKUS and ADVAIR HFA for more information or ask your healthcare provider or pharmacist.

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2. Common side effects of ADVAIR HFA for asthma include upper respiratory tract infection, throat irritation, hoarseness and voice changes, headache, dizziness, and nausea and vomiting. Rinse your mouth with water without swallowing after using ADVAIR to help reduce your chance of getting thrush.

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RISKS AND SIDE EFFECTS FOR ADVAIR DISKUS

Do not use ADVAIR DISKUS:

• to relieve sudden breathing problems
• as a rescue inhaler
• if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
• if you are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR DISKUS. See 'What are the ingredients in ADVAIR DISKUS?' below for the complete list of ingredients.

Tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems.
• have high blood pressure.
• have seizures.
• have thyroid problems.
• have diabetes.
• have liver problems.
• have weak bones (osteoporosis).
• have an immune system problem.
• have or have had eye problems, such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.
• are allergic to milk proteins.
• have any type of viral, bacterial, or fungal infection.
• are exposed to chickenpox or measles.
• are pregnant or plan to become pregnant. It is not known if ADVAIR DISKUS may harm your unborn baby.
• are breastfeeding. It is not known if the medicines in ADVAIR DISKUS pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADVAIR DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Read the step-by-step instructions for using ADVAIR DISKUS at the end of the Patient Information for ADVAIR DISKUS.

• Do not use ADVAIR DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
• Children should use ADVAIR DISKUS with an adult's help, as instructed by the child's healthcare provider.
• ADVAIR DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
• Use ADVAIR DISKUS exactly as your healthcare provider tells you to use it. Do not use ADVAIR DISKUS more often than prescribed.
• Use 1 inhalation of ADVAIR DISKUS 2 times each day. Use ADVAIR DISKUS at the same time each day, about 12 hours apart.
• If you miss a dose of ADVAIR DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• If you take too much ADVAIR DISKUS, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
• Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
• Do not stop using ADVAIR DISKUS, even if you are feeling better, unless your healthcare provider tells you to.
• ADVAIR DISKUS does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Rinse your mouth with water without swallowing after each dose of ADVAIR DISKUS. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
• Call your healthcare provider or get medical care right away if:
  • your breathing problems get worse.
  • you need to use your rescue inhaler more often than usual.
  • your rescue inhaler does not work as well to relieve your symptoms.
  • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
  • you use 1 whole canister of your rescue inhaler in 8 weeks.
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • you have asthma and your symptoms do not improve after using ADVAIR DISKUS regularly for 1 week.

ADVAIR DISKUS can cause serious side effects, including:

• fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.
• pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
  • increase in mucus (sputum) production
  • change in mucus color
  • fever
  • chills
  • increased cough
  • increased breathing problems
• weakened immune system and increased chance of getting infections (immunosuppression)
• reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR DISKUS). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
  • feeling tired
  • lack of energy
  • weakness
  • nausea and vomiting
  • low blood pressure (hypotension)
• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR DISKUS and call your healthcare provider right away.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of your face, mouth, and tongue
  • breathing problems
• effects on heart
  • increased blood pressure
  • a fast or irregular heartbeat
  • chest pain
• effects on nervous system
  • tremor
  • nervousness
• bone thinning or weakness (osteoporosis)
• slowed growth in children. A child's growth should be checked regularly by the healthcare provider while using ADVAIR DISKUS.
• eye problems including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using ADVAIR DISKUS.
• changes in laboratory blood levels (sugar, potassium, certain types of white blood cells)

Common side effects of ADVAIR DISKUS include:

Asthma:

• upper respiratory tract infection
• throat irritation
• hoarseness and voice changes
• thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• bronchitis
• cough
• headache
• nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

COPD:

• thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• throat irritation
• hoarseness and voice changes
• viral respiratory infections
• headache
• muscle and bone pain

These are not all the possible side effects of ADVAIR DISKUS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store ADVAIR DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
• Store ADVAIR DISKUS in the unopened foil pouch and only open when ready for use.
• Safely throw away ADVAIR DISKUS in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.

Keep ADVAIR DISKUS and all medicines out of the reach of children.

Active ingredients: fluticasone propionate, salmeterol xinafoate

Inactive ingredient: lactose monohydrate (contains milk proteins)

RISKS AND SIDE EFFECTS FOR ADVAIR HFA

Do not use ADVAIR HFA:

• to relieve sudden breathing problems.
• as a rescue inhaler
• if you are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR HFA. See 'What are the ingredients in ADVAIR HFA?' below for the complete list of ingredients.

Tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems.
• have high blood pressure.
• have seizures.
• have thyroid problems.
• have diabetes.
• have liver problems.
• have weak bones (osteoporosis).
• have an immune system problem.
• have or have had eye problems, such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.
• have any type of viral, bacterial, or fungal infection.
• are exposed to chickenpox or measles.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if ADVAIR HFA may harm your unborn baby.
• are breastfeeding. It is not known if the medicines in ADVAIR HFA pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADVAIR HFA and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Read the step-by-step instructions for using ADVAIR HFA at the end of the Patient Information for ADVAIR HFA.

• Do not use ADVAIR HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
• ADVAIR HFA comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
• Use ADVAIR HFA exactly as your healthcare provider tells you to use it. Do not use ADVAIR HFA more often than prescribed.
• Use 2 inhalations of ADVAIR HFA 2 times each day. Use ADVAIR HFA at the same time each day, about 12 hours apart.
• If you miss a dose of ADVAIR HFA, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• If you take too much ADVAIR HFA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
• Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
• Do not stop using ADVAIR HFA, even if you are feeling better, unless your healthcare provider tells you to.
• Talk to your healthcare provider right away if you stop using ADVAIR HFA.
• ADVAIR HFA does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Rinse your mouth with water without swallowing after each dose of ADVAIR HFA. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
• Call your healthcare provider or get medical care right away if:
  • your breathing problems get worse.
  • you need to use your rescue inhaler more often than usual.
  • your rescue inhaler does not work as well to relieve your symptoms.
  • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
  • you use 1 whole canister of your rescue inhaler in 8 weeks.
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • you have asthma and your symptoms do not improve after using ADVAIR HFA regularly for 1 week.

ADVAIR HFA can cause serious side effects, including:

• fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR HFA to help decrease your chance of getting thrush.
• pneumonia. ADVAIR HFA contains the same medicine found in ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder). ADVAIR DISKUS is used to treat people with asthma and people with chronic obstructive pulmonary disease (COPD). People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of you getting pneumonia. It is not known if ADVAIR HFA is safe and effective in people with COPD. Call your healthcare provider right away if you have any of the following symptoms:
  • increase in mucus (sputum) production
  • change in mucus color
  • fever
  • chills
  • increased cough
  • increased breathing problems
• weakened immune system and increased chance of getting infections (immunosuppression).
• reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR HFA). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
  • feeling tired
  • lack of energy
  • weakness
  • nausea and vomiting
  • low blood pressure (hypotension)
• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR HFA and call your healthcare provider right away.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of your face, mouth, and tongue
  • breathing problems
• effects on heart.
  • increased blood pressure
  • a fast or irregular heartbeat
  • chest pain
• effects on nervous system.
  • tremor
  • nervousness
• bone thinning or weakness (osteoporosis).
• slowed growth in children. A child's growth should be checked regularly by the healthcare provider while using ADVAIR HFA.
• eye problems including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using ADVAIR HFA.
• changes in laboratory blood levels (sugar, potassium, certain types of white blood cells).

Common side effects of ADVAIR HFA include:

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• upper respiratory tract infection
• throat irritation
• hoarseness and voice changes
• headache
• dizziness
• nausea and vomiting

These are not all the possible side effects of ADVAIR HFA.

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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store ADVAIR HFA at room temperature between 68°F and 77°F (20°C and 25°C) with the mouthpiece down.
• The contents of your ADVAIR HFA are under pressure: Do not puncture. Do not use or store near heat or open flame. Temperatures above 120°F may cause the canister to burst.
• Do not throw into fire or an incinerator.
• Safely throw away ADVAIR HFA in the trash when the counter reads 000.

Keep ADVAIR HFA and all medicines out of the reach of children.

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Active ingredients: fluticasone propionate, salmeterol xinafoate

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Inactive ingredient: propellant HFA-134a